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Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive

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ClinicalTrials.gov Identifier: NCT03080467
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief Summary:
This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.

Condition or disease
Tissue Adhesives Laceration Sutures Wounds and Injuries Child

Detailed Description:

Investigation of the long-term outcome of 400 pediatric patients with traumatic skin lacerations in the head area. After primary wound repair with suture or with tissue adhesive, eligible patients will be enrolled on the emergency department (baseline visit). The second follow-up visit will take place 5-10 days after the baseline visit and the third follow-up visit will be completed 6-12 months after trauma. At both follow-up visits, clinical examination and a brief interview will be performed. Photo documentation is completed at both the baseline and the follow-up visit.

Encrypted photo documentation will be evaluated by blinded external plastic surgeons. Primary Outcome is the cosmetic appearance using standard assessment scales, secondary outcomes are the occurrence of complications, cost-effectiveness and patient's satisfaction.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcome of the Primary Wound Repair of Traumatic Skin Lacerations in the Head Area in Pediatric Patients: Suture Versus Tissue Adhesive
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Wound repair with suture
Tissue adhesive
Wound repair with tissue adhesive

Primary Outcome Measures :
  1. Cosmetic scar appearance [ Time Frame: second follow-up visit: 6 till 12 months after wound repair ]
    Cosmetic appearance will be assessed using the modified Patient and Observer Scar Measurement Score

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients after completion of a primary wound repair treatment with suture or tissue adhesive in the Pediatric Emergency Unit

Inclusion Criteria:

  • 0 till16 years of age
  • Any primary wound repair treatment of a laceration caused by trauma and involving the skin of the head area
  • Patient or caregiver must be able to understand and sign an informed consent

Exclusion Criteria:

  • Pre-existing conditions that affect wound healing adversely
  • Patients who demonstrate severe or life-threatening injuries
  • Patients / caregivers with communication / logistic barriers that would make them unfit to provide informed consent or to attend the follow-up visits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080467

Contact: Sonja Fontana, MD +41442667106 Sonja.Fontana@kispi.uzh.ch
Contact: Georg Staubli, MD +41442668126 Georg.Staubli@kispi.uzh.ch

Children's University Hospital of Zurich Recruiting
Zurich, ZH, Switzerland, 8032
Contact: Sonja Fontana, MD    +41442667111 ext 7106    sonja.fontana@kispi.uzh.ch   
Contact: Georg Staubli, MD    +41442667111    georg.staubli@kispi.uzh.ch   
Sponsors and Collaborators
University Children's Hospital, Zurich
Principal Investigator: Clemens M Schiestl, PD Children's University Hospital of Zurich


Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03080467     History of Changes
Other Study ID Numbers: 2016-01304
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Children's Hospital, Zurich:
Tissue adhesive
Lip lacerations
Skalp lacerations
Facial injuries

Additional relevant MeSH terms:
Wounds and Injuries